GrowWell - Responsive Bottle Feeding

Not Applicable

Active, not recruiting

• Conditions: Bottle Feeding

• Registration Number: NCT06319807
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

The overall goal of this research is use digital health to augment the clinical encounter with Women, Infants, and Children (WIC) clinicians and prevent rapid infant weight gain among children living in low-income households. Intervening on weight gain during infancy offers an opportunity to influence lifelong obesity risk. Using personalized motivational messages and targeted skills-training resources, the intervention will support parents and caregivers in adopting responsive feeding strategies. Knowledge gained from this project will be used to develop a future, larger grant submission focused on developing healthy feeding and eating habits among mother-infant dyads.

Detailed Description

Assess the feasibility and acceptability of a digital intervention aimed at increasing responsive infant feeding behaviors, beginning 1 month postpartum and continuing through 3-months postpartum, among a prospective cohort of women receiving WIC benefits.

Use qualitative methods to explore barriers and facilitators to participation in a digital infant feeding intervention among women receiving WIC benefits during early postpartum

Study Timeline

• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-19
• Study First Posted: 2024-03-20
• Study Start: 2024-10-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-06-03
• Last Update Posted: 2025-06-04
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 69

Inclusion Criteria

• Aged ≥18 years
• as a smartphone and an email address
• willing to send and receive daily text messages
• can read and write in English
• child is <=6 weeks

Exclusion Criteria

• participating in in a different research study that, in the opinion of the investigator, would conflict or would otherwise be too problematic if the subject were to participate in this study
• planning to leave North Carolina in the next 6 months
• subjects who do not have the capacity to give legally effective consent
• any medical or congenital condition that would interfere with infant feeding or growth (ie, Down syndrome or cleft lip or palate)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Engagement - average text message completion rate	Week 12	Engagement will be assessed by reporting the average text message completion rate over the 12-week intervention period.

Secondary Outcome Measures

Name	Time	Method
Satisfaction Scores - Acceptability	Week 12	Satisfaction with the intervention content - Participants will be asked to complete satisfaction surveys upon study completion to assess the acceptability of the message perceptions about the use of digital technologies. There isn't a scale; we will report percentage responding positively to each question.
Satisfaction Scores - Frequency	Week 12	Satisfaction with the intervention message frequency - Participants will be asked to complete satisfaction surveys upon study completion to assess the frequency of the use of digital technologies. There isn't a scale; we will report percentage responding positively to each question.
Satisfaction Scores - Timing	Week 12	Satisfaction with the intervention message timing - Participants will be asked to complete satisfaction surveys upon study completion to assess the timing, of the use of digital technologies. There isn't a scale; we will report percentage responding positively to each question.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States